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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K040396
Device Name ULTRASONIC SCALER ELEGANCE MS-10 (25K)
Applicant
Rolence Enteprise, Inc.
18-3, Ln. 231
Pu-Chung Rd.
Chungi,  TW 320
Applicant Contact STERLING CHENG
Correspondent
Rolence Enteprise, Inc.
18-3, Ln. 231
Pu-Chung Rd.
Chungi,  TW 320
Correspondent Contact STERLING CHENG
Regulation Number872.4850
Classification Product Code
ELC  
Date Received02/17/2004
Decision Date 04/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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